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MsFLASH-01: Escitalopram for Menopausal Symptoms in Midlife Women

NCT00894543 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 205

Last updated 2013-03-08

Study results available
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Summary

The purpose of this study is to test whether a medication reduces the number, severity and bothersomeness of menopausal hot flashes. Escitalopram (also called Lexapro®) is a selective serotonin reuptake inhibitor (SSRI). It is sold by prescription for depression and general anxiety disorder. An SSRI increases serotonin, a brain substance that is believed to influence mood. Serotonin may also affect brain levels of estradiol, a hormone related to hot flashes. This research study will test whether escitalopram reduces menopausal hot flashes.

Conditions

Interventions

DRUG

Escitalopram

10 mg (1 pill) escitalopram daily for the first four weeks. Dose increased to 20 mg (2 pills) escitalopram daily if relief from hot flashes has not occurred during the first four weeks of the daily 10 mg dose.

OTHER

Placebo

Inactive pill (1 pill or 2 pills) daily for the 8-11 weeks of the trial.

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • National Center for Complementary and Integrative Health (NCCIH)

    collaborator NIH

  • Office of Research on Women's Health (ORWH)

    collaborator NIH

  • Fred Hutchinson Cancer Center

    lead OTHER

Principal Investigators

  • Ellen W Freeman, PhD · University of Pennsylvania Medical Center

  • Andrea Z LaCroix, PhD · Fred Hutchinson Cancer Center

  • Garnet L Anderson, PhD · Fred Hutchinson Cancer Center

  • Kris Ensrud, MD · University of Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
62 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2010-06-30
Completion
2010-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00894543 on ClinicalTrials.gov